Drug product
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054
D-0133-2017
Product summary
- Firm
- Sandoz Inc
- Event
- Event 75168
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42,740 cartons (24 count carton from 7 total lots)
- Official record key
drug-enforcement:D-0133-2017
Official wording
Reason: Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
Code information: NDC 10019-553-02 (24 ct. carton) and NDC 10019-553-88 (patch); Lot #'s FV5908 and FX1520 both with expiry 06/2018; GB4910 and GC4210 both with expiry 09/2018; GE1927 with expiry 12/2018; GF7017 with expiry 01/2019 and GH8065 with expiry 02/2019.
Distribution pattern: TN
Derived failure modes
-
Unknown
Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.